An ampoule is a small glass vial sealed after filling chiefly used as a container for a hypodermic injection solution. Ampoules come in many sizes, but generally hold about 0.5 to 50 ml of solution. Ampoules typically include a cylindrical body portion having a closed end. An opposing end includes a necked portion extending radially inwardly. The opposing end is sealed, generally by a thin membrane capable of being penetrated by a needle-type syringe.
Ampoules are produced from glass for several reasons. Glass can be produced to a very translucent clarity. This allows a user to observe the contents of the ampoule, which could be very important depending on the injectable. Glass is also very inert. Though countless efforts have been made to produce a polymer suitable for storing injectables, the medical industry still fears that reactions between the injectable and the polymer could cause deleterious leaching of the polymer into the injectable. Because glass is very stable, such leaching is not a concern.
However, there are drawbacks to glass ampoules. Glass ampoules can break if dropped. At best, this can cause a simple mess and minor hazard due to small shards of glass. At worst, it can cause a bio-medical hazard when the ampoule contains a more volatile or dangerous injectable. Glass is also slick and difficult for some users to handle. And while the clarity of glass is a benefit, it can also be a drawback when the injectable is sensitive to light. The pharmaceutical industry has been conducting research into the use of materials other than glass in the construction of ampoules. They have found some substrates that may work but their cost is significantly higher than that of glass.
Glass ampoules are often used for the storage/transfer of insulin. Insulin allows diabetes sufferers to control their blood sugar (glucose). Insulin cannot be taken by mouth because it would be destroyed by digestion. Instead, most people who need insulin take insulin injections. Therefore, many diabetes sufferers rely on insulin-filled glass ampoules to help treat their disease.
There are more than 20 types of insulin products available in four basic forms, each with a different time of onset and duration of action. The decision as to which insulin to choose is based on an individual's lifestyle, a physician's preference and experience, and the person's blood sugar levels. Some examples of insulin analogs are rapid-acting, short-acting, intermediate-acting, intermediate- and short-acting mixtures, and long-acting.
Blindness often accompanies diabetes. Very early, it was established that blind diabetics could more safely and reliably distinguish between insulin types, thus reducing dangerous dosage errors if codes, other than color coded caps, were included on the ampoules. It was suggested that there be a marking system: one through four horizontal bars on the label of every ampoule of insulin sold in the United States. A single bar would identify rapid acting analogs; two bars would identify regular insulins; three bars would indicate mixed insulin; and four bars would indicate the longer-acting insulins.
The present invention is provided to solve the problems discussed above and to provide advantages and aspects not provided by prior containers of this type. A full discussion of the features and advantages of the present invention is deferred to the following detailed description, which proceeds with reference to the accompanying drawings.